title: The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention.
abstract: OBJECTIVE
  We sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of antiplatelet therapy and no anticoagulation therapy.
  
  
  BACKGROUND
  Available guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications.
  
  
  METHODS
  From June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI.
  
  
  RESULTS
  Procedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% [95% confidence interval: -0.1% to 4.5%], p for superiority = 0.17, p for noninferiority <0.001).
  
  
  CONCLUSIONS
  In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.
authors.affiliation: Laboratory of Invasive Cardiology, Division of Cardiology, Clinica Montevergine, Mercogliano, Italy. geko50@hotmail.com
authors.forename: Eugenio
authors.initials: E
authors.lastname: Stabile
authors.forename: Wail
authors.initials: W
authors.lastname: Nammas
authors.forename: Luigi
authors.initials: L
authors.lastname: Salemme
authors.forename: Giovanni
authors.initials: G
authors.lastname: Sorropago
authors.forename: Angelo
authors.initials: A
authors.lastname: Cioppa
authors.forename: Tullio
authors.initials: T
authors.lastname: Tesorio
authors.forename: Vittorio
authors.initials: V
authors.lastname: Ambrosini
authors.forename: Esther
authors.initials: E
authors.lastname: Campopiano
authors.forename: Gregory
authors.initials: G
authors.lastname: Popusoi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi Zoccai
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004311:Double-Blind Method; D017558:Elective Surgical Procedures / Q000379:methods* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D006493:Heparin